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April 2019 / Vol 13 / Supplement 1 ISSN 1658-354X

Saudi Journal of

AnesthesiaSaudi Journal of

AnesthesiaThe official publication of Saudi Anesthesia Society

www.saudianas.com

www.saudija.org

Spine 5 mm

Special issue on:"How to write a scientific paper"

S27© 2019 Saudi Journal of Anesthesia | Published by Wolters Kluwer - Medknow

Sarah CuschieriDepartment of Anatomy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta

Address for correspondence: Dr. Sarah Cuschieri, Department of Anatomy, Faculty of Medicine and Surgery, Biomedical Building, University of Malta, Msida MSD 2080, Malta. E‑mail: sarah.cuschieri@um.edu.mt

ABSTRACTRandomized control trials (RCT’s) are the gold standard in evaluating and efficiently translating research data into clinical practice. The CONSORT statement was conceptualized in order to help ascertain standardization and reproducibility of RCT’s. The articles publishing the CONSORT 2010 statement along with their bibliographies were identified and thoroughly reviewed. The CONSORT statement is made up of a 25-item checklist that provides the author with a solid backbone around which to construct and present an RCT. It sets standards on the trial’s design, analysis, and interpretation of the results.

Key words: Data reporting; epidemiology; publishing; research; research design

Introduction

Different epidemiological study designs are available, one of which is the randomized control trial (RCT). RCTs are the gold standard in evaluating and efficiently translating research data into clinical practice. In fact, this type of study provides the fundamentals of evidence‑based medicine and is the most reliable research design out of all of the epidemiological studies available.[1] Therefore reporting of these invaluable interventions require high‑quality reporting techniques, which allow transparency while enabling the readers to critically appraise the trial findings. In order to avoid systematic reporting errors while ascertaining the high‑quality reporting standards of RCTs, the CONSORT statement was coined in 1996.[2] The CONSORT was revised over the years to provide clearer explanations and elaborations of the CONSORT principles. The last version was established in 2010 (available at www.consort‑statement.org), on which this article will be based.[2] In fact, the original articles publishing the CONSORT 2010 statement together with their bibliographies were identified and thoroughly reviewed.

The CONSORT Statement

The CONSORT stands for “Consolidated Standards of Reporting Trails” and was developed to aid authors to present the RCTs in a clean, transparent and complete manner, and not to act as a quality assessment tool. The CONSORT is composed of a 25‑item checklist, which focuses on the reporting of the trial design, analysis, and interpretation, as seen in Table 1.[2–4] A CONSORT flowchart is also available, which displays the progress of all participants through the trail, as seen in Figure 1.[4]

The CONSORT checklist

A brief description of each checklist item is provided below.[2,3]

Item 1: Title and abstractThe manuscript title should include the words “randomized trial” in order to ensure correct indexing of the manuscript in electronic databases. Indexing of the published manuscript is of utmost importance to ensure identification of the

The CONSORT statement

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How to cite this article: Cuschieri S. The CONSORT statement. Saudi J Anaesth 2019;13:S27-30.

Cuschieri: CONSORT - Guidelines for publishing random control trials

S28 Saudi Journal of Anesthesia / Volume 13 / Supplement 1 / April 2019

Table 1: The CONSORT 2010 checklist

CONSORT 2010 checklistSection/topic Item number Checklist itemTitle and abstract 1a Identification as a randomized trial in the title

1b Structured summary of trial design, methods, results, and conclusionsIntroduction

Background and objectives 2a Scientific background and explanation of the rationale2b Specific objectives or hypotheses

MethodsTrial design 3a Description of trial design (such as parallel, factorial) including allocation ratio

3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons

Participants 4a Eligibility criteria for participants4b Settings and locations where the data were collected

Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

6b Any changes to trial outcomes after the trial commenced, with reasonsSample size 7a How sample size was determined?

7b When applicable, explanation of any interim analyses and stopping guidelinesRandomization

Sequence generation 8a The method used to generate the random allocation sequence8b Type of randomization; details of any restriction (such as blocking and block size)

Allocation concealment mechanism 9 The mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

Blinding 11a If done, who was blinded after assignment to interventions (e.g., participants, care providers, those assessing outcomes) and how

11b If relevant, description of the similarity of interventionsStatistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes

12b Methods for additional analyses, such as subgroup analyses and adjusted analysesResults

Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned received intended treatment and were analyzed for the primary outcome

13b For each group, losses and exclusions after randomization, together with reasonsRecruitment 14a Dates defining the periods of recruitment and follow-up

14b Why the trial ended or was stoppedBaseline data 15 A table showing the baseline demographic and clinical characteristics for each groupNumbers analyzed 16 For each group, number of participants (denominator) included in each analysis and

whether the analysis was by original assigned groupsOutcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated

effect size and its precision (such as 95% confidence interval)17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended

Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

DiscussionLimitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, the

multiplicity of analysesGeneralizability 21 Generalizability (external validity, applicability) of the trial findingsInterpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering

other relevant evidenceOther information

Registration 23 Registration number and name of trial registryProtocol 24 Where the full trial protocol can be accessed, if availableFunding 25 Sources of funding and other support (such as the supply of drugs), the role of funders

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manuscript as describing a trial. Furthermore, correct indexing also enhances the visibility of a researcher’s work and increases the citation potential of the published manuscript. Citation of published manuscripts is imperative for the enhancement of the researcher’s research metrics and for increasing the prestigious acknowledgment of the researcher and his/her work within the scientific community.[5]

The abstract should include a structured, brief, and clear summary of the study while presenting information found within the actual body of the manuscript. The abstract needs to be well written, since readers tend to assess the overall quality of the trial just by reading the abstract. Furthermore, since not all trial reports are fully freely available for readers, the abstract may be the only source of initial information accessible to readers.[3]

Item 2: IntroductionThe Introduction section sets the scientific scene and rational as to why the trial was essential. Trials involving human subjects should have an ethical clearance and exhibit substantial benefit toward mankind.

The objective and hypothesis set out to be investigated in the trial should be reported clearly in this section.

Item 3 to 12: MethodsThe Methods section should include a detailed report of how the trial was conducted including the type of design followed and the description of the protocol followed. The type of trial conducted needs to be noted clearly i.e., whether it consisted of a parallel group design or a factorial design.[3] The most common trial design followed is a randomized parallel group design, and in fact the CONSORT statement focuses mainly on such a trial design.[6] It is essential that all the eligibility criteria utilized in the trial protocol are clearly defined since this will enable the reader to interpret the study results adequately. Furthermore, the setting and location (county, city, hospital, and clinic) of the trial needs to be reported, since such information impacts on the study’s validity.[3]

Sufficient detail on the intervention and the control groups are required to enable the reproducibility of the trial. When a drug intervention trial is being reported, it is essential that the drug name, dose, mode of administration, timing, and duration details are provided.

The outcome measures, be it primary or secondary outcome, should be identified and defined as part of the Methods section in order to allow readers to use the same outcomes for their own setting.[7] It is not uncommon that the initial

Figure 1: The CONSORT 2010 flowchart

Enrollment Assessed for eligibility (n = )

Excluded (n = )• Not meeting inclusion criteria (n = )• Declined to participate (n = )• Other reasons (n = )

Randomized (n = )

Allocated to intervention (n = )• Received allocated intervention (n = )• Did not receive allocated intervention (give reasons) (n = )

Allocated to intervention (n = )• Received allocated intervention (n = )• Did not receive allocated intervention (give reasons) (n = )

Lost to follow-up (give reasons) (n = )Discontinued intervention (give reasons)(n = )

Lost to follow-up (give reasons) (n = )Discontinued intervention (givereasons) (n = )

Analyzed (n = )• Excluded from analysis (give reasons) (n = )

Analyzed (n = )• Excluded from analysis (give reasons) (n = )

Allocation

Follow-Up

Analysis

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S30 Saudi Journal of Anesthesia / Volume 13 / Supplement 1 / April 2019

objective and protocol are amended throughout the course of the trial. In which case, this change should be reported.

The process of establishing an ethically and scientifically approved trial sample size needs to be noted and justified. Such information needs to provide evidence of the statistical power of the sample population under study. Furthermore, the randomization protocol of the sample population into the intervention and the control groups must be noted. Trials that follow a blinding protocol need to ensure the following: how such blinding was done, who knew about the blinding, was blinding initiated from the start of the trial, among other details. This is to ensure that any potential bias in the results is identified and accounted for.[3]

A detailed description of all the statistical analyses of the data obtained from all stages of the trial needs to be reported.

Item 13 to 19: ResultsThe CONSORT flowchart, as seen in Figure 1, is provided to guide the author to the details required in the Results section. It is strongly recommended that the author utilizes the CONSORT flowchart to illustrate the trial outcomes. A detailed account of the intervention and the control groups are required including any loss of follow‑up and any individual exclusion that occurred during the trial. If the trial ended prematurely, the reasons contributing to this need to be reported. It is suggestible to illustrate the baseline characteristics of the population under study followed by the primary and secondary outcomes of the study. Furthermore, any harms or unintended effects originating from the trial need to be reported.

Item 20 to 22: DiscussionThe Discussion section should include supporting evidence to the trial’s findings along with the pros and cons of the results obtained. Any external validation performed needs to be reported and discussed.

Item 23: Other informationThe clinical trial should be registered at the very beginning in order to avoid any patency or infringement issues.

Such details are required to be included in the manuscript reporting the clinical trial. The details of where a reader can access the full trial protocol needs to be included as well. Clinical trials are very expensive to conduct and funding will be required for it to be successful. All funding sources and the role of the funders in the trial’s protocol are imperative to be stated in manuscripts.

Conclusion

The CONSORT statement is a constantly updated guideline developed to aid RCTs authors in adequately reporting any trial. A 25‑checklist and a flowchart comprise the CONSORT statement. Reporting and publishing trials in any journal require the authors to follow the CONSORT statement while writing their manuscript to ensure publication consideration.

Financial support and sponsorshipNil.

Conflicts of interestThere are no conflicts of interest.

References

1. Spieth PM, Kubasch AS, Penzlin AI, Illigens BM, Barlinn K, Siepmann T, et al. Randomized controlled trials – A matter of design. Neuropsychiatr Dis Treat 2016;12:1341-9.

2. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.

3. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 2010;63:e1-37.

4. Consort-Welcome to the CONSORT Website, Available from: http://www.consort-statement.org/. [Last accessed on 2018 Aug 21].

5. CuschieriS.WASP(Writeascientificpaper):Understandingresearchmetrics. Early Hum Dev 2018;118:67-71.

6. Chan AW, Altman DG. Epidemiology and reporting of randomised trials published in pubMed journals. Lancet 2005;365:1159-62.

7. Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ 2008;336:1472-4.